Manager, Research Nurse

Job Description:

The Research Nurse Manager ensures the integrity and quality of clinical trials are maintained and conducted in accordance with international, federal, state, and local regulations, and Institutional Review Board (IRB) approvals.  This role involves recruiting, supervising, evaluating, and coordinating the activities of a team of professional nurses and/or clinical research support staff; ensures that all clinical activities are carried out in accordance with established research protocol, and with acceptable clinical procedure and safety standards.

ESSENTIAL FUNCTIONS:

• Manage day-to-day clinical research nursing operations, from protocol review/initiation to study close-out, ensuring study integrity throughout, under the guidance of the Principal Investigator (PI) and in collaboration with the clinical/medical officer assigned to the study.
• Oversees daily clinical operations of the Research Nursing Department.
• Ensure clinical staffing needs are met and manage scheduling.
• Ensures staff compliance with clinical and research standard operating procedures.
• Assists adherence to study-related SOPs/scientific manuals; plans, conducts, and evaluates study orientation, oversees protocol-related in-services to research team and clinical staff; institutes process improvements as needed.
• Conducts staff meetings and training sessions.
• Generates performance evaluations and proposes disciplinary actions when appropriate.
• Defines activities in complex clinical research studies to prevent deviations/unanticipated events.
• Provides expertise and leadership in the development, preparation, and implementation of regulatory strategies to support clinical research missions.
• Manages the tasks of direct reports to guide patients through the processes of consenting, screening, treatment, and post-treatment follow-up in clinical trials.
• Ensure timely collection and reporting of adverse events according to institutional, sponsor and FDA timelines.
• Supervises direct reports in the performance of medical tests, including, but not limited to, vital signs, lab, and EKGs.
• Collaborates with other research managers in the management of staff, resources/allocation planning and performance assessments for various clinical research, clinical trials implementation and oversight and regulatory and compliance functions.
• Communicates and collaborates w/ study team including internal and external parties, sponsors, PI, and study participants.
• Evaluates potential protocols to determine feasibility, resource requirements.
• Assists in the development and implementation of clinical research technology systems and infrastructure.
• Develops protocol needs assessment and monitors quality assurance protocol for services provided.
• Prepares for and attends sponsor and FDA audits.
• Provides nursing care to research study patients; ensures compliance with each study's protocol; administers investigational medications and performs patient assessment during clinical visits as needed.
• Ensures that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines.
• Travel to all research site offices as necessary.
• Maintains a professional approach respecting the dignity and confidentiality of patients.
• Maintains a good attendance record and reports to work on time.
• Maintains a professional attitude and appearance.
• Maintain Tennessee licensure as applicable.
• Performs other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES:

• Excellent verbal and written communication skills.
• Strong organizational and follow-up skills.
• Ability to handle multiple priorities in a fast-paced environment.
• Understanding complex clinical trials protocols.
• Ability to direct, manage, implement, and evaluate department operations.
• Ability to establish department goals, and objectives that support strategic plan.
• Effective planning, delegation, and supervision skills.
• Ability to travel up to 25% (local/regional).
• Proficiency in Microsoft Office products (Word, Excel, PowerPoint, etc.)

• Knowledge of protocol and clinical drug development processes, study design, study planning and management, and monitoring.
• Knowledge of ICH/GCP guidelines

EDUCATION & EXPERIENCE:

• Associate in nursing or Bachelor’s in nursing required.
• Current Tennessee RN license
• 5+ years of experience as registered nurse
• 3+ years of experience in oncology setting
• Previous clinical research experience required, oncology research preferred.
• Previous supervisory and/or management experience, preferred